FUJIFILM : Cellular Dynamics International granted iPS cell generation patent in Japan.

October 18, 2016

FUJIFILM Corporation (President: Kenji Sukeno) has announced that US-based Cellular Dynamics International Inc., (hereinafter 'CDI'), a subsidiary of Fujifilm and the leading developer and manufacturer of induced pluripotent stem cells (iPS cells), has been granted a patent in Japan related to technology required for the safe and efficient generation of iPS cells. iPS cells made from peripheral blood with episomal vectors are widely used around the world in Japan, the US and other countries and require the patents of both CDI and Center for iPS Cell Research and Application of Kyoto University for the generation.

With the acquisition of this patent, Fujifilm aims to harness synergies across the Fujifilm Group, by leveraging assets including Fujifilm's engineering technology and the quality management systems in place at Japan Tissue Engineering Co., Ltd. (hereinafter 'J-TEC'), one of the Fujifilm Group companies, in order to expand its iPS cells contract manufacturing business.

Since its foundation, CDI has engaged continually in research and development of iPS cells for drug discovery support and cell therapy applications. This research and development has resulted in the establishment of core technology related to generate iPS cells in pursuing an iPS cell business. CDI had already been granted patents for this technology in the US and Australia and has now been granted the same patent in Japan.

The patent is for a process involving the extraction of blood cells in a sterile, minimally-invasive procedure (in the same way as a normal blood sample) followed by the use of episomal vectors*to introduce multiple genes without damaging the blood cell genes in order to achieve the safe and efficient generation of iPS cells.

[ Patent Details ]
Patent name : Generation of induced pluripotent stem cells (iPS cells) from small volumes of peripheral blood
Patent no. : Japan patent 5984217
Key points of patent:

• The use of human peripheral blood cells for generating iPS cells
• The use of episomal vectors to introduce genes for reprogramming the cell
• The introduction of two or more genes using a single episomal vector
• No use of feeder cells**when cultivating the cells

CDI supplies products such as iPS cells used in drug discovery screening and toxicity tests for new drug developments for parties including major pharmaceutical companies and advanced research institutions around the world Currently, the company is accelerating the development of cells for use in therapy, and it plans to establish an iPS cell bank with 12 different HLA types***in the US as early as next year. These cells are relatively resistant to immune system rejection. Furthermore, the company intends to leverage the knowledge and know-how about iPS cells in order to achieve advances in cell therapy in other fields such as age-related macular degeneration, Parkinson's disease and heart diseases.

By harnessing the resources of group companies including J-TEC, CDI and Cellular Dynamics International Japan, Fujifilm Group is working to further expand regenerative medicine business based on iPS cells and contribute to the elevation of regenerative medicine business to the industrial stage

• *Using episomal vectors results in the replication of the introduced genes at the time of cell division. In contrast to gene introduction using viruses, the introduced genes do not combine with the DNA of the cells that will form the iPS cell, and therefore this vector allows genes to be introduced safely.
• **Feeder cells are used when cultivating cells and play a supplementary role in producing the necessary environment for the replication and division of the target cells. Fibroblasts from mice are used.
• ***Human Leukocyte Antigen (HLA) is contained within almost all human cells and bodily fluids and functions as a histocompatibility antigen (an important molecule for the human immune system). When transplants of hemopoietic stem cells or organs are conducted, all cells that do not match the recipient's HLA are rejected as foreign bodies, and therefore HLA compatibility is important due to the need to suppress rejection by the immune system.

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